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Under what authority is CDC issuing these regulations?

The Secretary of Health and Human Services has the legal authority to establish regulations outlining the requirements for the medical examination of aliens before they may be admitted into the United States. This authority is provided under Section 212(a)(1)(A) of the Immigration and Nationality Act (8 U.S.C. § 1182(a)(1)(A)) and Section 325 of the Public Health Service Act.

These regulations establish requirements that determine whether aliens can be admitted into the United States.

What is the medical examination of aliens?

Aliens are screened for any “communicable disease of public health significance” and other inadmissible medical conditions to determine if they can enter the United States. This helps to safeguard the American public from serious disease threats. These medical assessments are conducted by doctors (panel physicians in foreign countries for applicants overseas and civil surgeons in the U.S. for those applicants already in this country and who are applying for adjustment of status to permanent resident.)

Who are considered aliens?

An alien is any person not a citizen or lawful permanent resident of the United States. Some types of aliens include immigrant, refugee, asylee or parolee as defined below:

An immigrant is a person from another country admitted to the United States as a lawful permanent resident.

A refugee is any person who is outside his or her country of nationality who is unable or unwilling to return to that country because of persecution or a well-founded fear of persecution based on race, religion, nationality, particular social group, or political opinion.

An asylee is considered the same as a refugee, except that an asylee applies for asylum status either upon arrival at a U.S. port of entry or after entry into the United States.

A parolee is a person from another country who appears to be inadmissible to the inspecting officer, but is allowed into the United States for urgent humanitarian reasons or when his or her entry is determined to be for significant public benefit.

What is a “communicable disease of public health significance” in Part 34?

Part 34 defines “communicable disease of public health significance” as a defined list including categories of diseases by which aliens are screened for during the required medical examination to determine eligibility for admission into the United States. Aliens may be excluded from entering the United States if one of these diseases is detected during the medical examination.

What changes have been made to the regulation?

CDC has amended the list of “communicable diseases of public health significance.” Because diseases emerge as public health threats faster than updates can be made through regulation change, the following two categories of diseases have been added:

Events that are reportable as a public health emergency of international concern (PHEIC) to the World Health Organization (WHO) under the International Health Regulations (IHR) of 2005 (currently polio, smallpox, SARS, influenza, and other public health emergencies of international concern.)

CDC has added a risk-based approach for aliens screened outside of the United States that is based on medical and epidemiologic factors, to determine when and where additional screening, testing and treatment for specific infectious diseases should be conducted.

CDC has updated screening and testing for tuberculosis to utilize current medical knowledge and practice.

Prior to these revisions, what diseases were considered a “communicable disease of public health significance?”

Why is CDC revising the regulation on medical screening of aliens?

There was a need to address emerging and re-emerging diseases in immigrant and refugee populations. CDC has modernized parts of the regulation to help safeguard the American public from communicable diseases in regions of the world where large numbers of U.S.-bound immigrants and refugees reside. The previous regulation did not allow the flexibility to monitor for emerging infectious diseases or unanticipated outbreaks overseas such as SARS or a new pandemic influenza virus.

These changes also allow for a risk-based approach to medical screening and testing. This approach allows CDC to determine the appropriate response to additional diseases of public health significance. This approach provides a flexible, fair and practical means to address infectious disease threats among at-risk aliens without placing an undue burden on other applicants to enter the U.S.

Updates to the medical screening for tuberculosis requirements were needed for better case detection of tuberculosis. The previous regulation was outdated and did not reflect current medical knowledge and practice.

Will these revisions to the regulation apply to those aliens residing in the United States?

The revisions to the regulations only apply to medical examinations performed outside of the United States and do not affect applicants living in the United States who apply for adjustment of status.

Does this Interim Final Rule (IFR) remove HIV infection or any other disease from the list of “communicable disease of public health significance?”

No. This IFR does not remove any disease from the list of communicable diseases of public health significance. CDC is actively working to further amend these regulations to remove HIV from the list so that otherwise eligible HIV-positive non-citizens may gain entry into the United States.

What happens when an applicant applying to enter the United States is determined to have a disease based on the revised definition of “communicable disease of public health significance”?

An applicant with a communicable disease of public health significance may or may not be immediately eligible to enter the United States depending on the severity or nature of their condition. Once an applicant receives treatment or recovers from their condition, they would be eligible to enter the United States if they are no longer a significant health risk to others and meet all other requirements.

What is a risk-based screening approach and how will it work?

Risk-based screening uses medical and epidemiologic criteria to determine the risk to others due to an outbreak of disease. If the risk of transmission of disease to others is thought to be high enough, it would warrant the screening of aliens for this condition based on the location and severity of the event. The disease or event will be considered a communicable disease of public health significance when it is determined to be strongly associated with the threat of importation and of having potential adverse effect on the health of the American public. This update is important since screening of aliens in the previous regulation was not based on the risk level of disease transmission.

Why use a risk-based screening approach?

CDC is unable to forecast the constantly changing migration patterns of immigrants and refugees, but must have the flexibility to respond swiftly as unpredictable, problematic health and humanitarian crises arise. Public health officials cannot predict which type of communicable diseases will occur and where they will happen. Using a risk-based approach for medical screening can anticipate potential health risks by tailoring medical screening and testing to a geographical location and prevalence of disease.

How will panel physicians know when and how to screen and test for diseases designated under the risk-based approach?

CDC develops and writes the Technical Instructions for the Medical Examination of Aliens. CDC will notify panel physicians when updates regarding new screening, testing, or treatment protocols are issued and will be made available on the CDC website. Their purpose is to instruct panel physicians on the process of medical screening and testing for medical conditions that would make applicants inadmissible for entry into the United States. Panel physicians will continue to use all current Technical Instructions to screen aliens, unless they are notified by CDC to screen for additional diseases designated through the risk-based approach. The risk-based system uses medical criteria to determine the origin, potential spread, and patterns of developing diseases to establish instructions on how long to screen and test for illness at a particular location. The CDC Technical Instructions for Medical Examination of Aliens, including the most current updates, which panel physicians must follow, are available to the public on the CDC website.

Will the medical examination of all aliens overseas be affected each time HHS/CDC’s risk-based analysis determines a disease requires additional screening?

The number of applicants affected will generally be restricted geographically to specific areas of concern. Thus, the risk-based process will respond to emerging threats, without overwhelming the entire health system with needless testing.

How will other new, emerging, or unknown diseases be added to the list of communicable diseases of public health significance?

The 2005 International Health Regulations (IHR) have a process to identify events of potential international public health concern from unknown causes or diseases that are not currently identified. CDC will apply the IHR risk-based screening algorithm to these diseases or events to determine if aliens should be examined for these new or reemerging illnesses.

How is CDC changing the screening for tuberculosis?

The former regulation required sputum (mucus coughed up from the lower airways) smears from anyone suspected of having tuberculosis. CDC has changed the regulation to agree with current medical guidelines that call for a culture for the organisms that causes tuberculosis. The culture will detect more cases of active tuberculosis than a sputum smear. CDC is also requiring a chest x-ray examination for applicants under the age of 15 when there is a reason to suspect tuberculosis infection. This rule also clarifies the use of tuberculin skin tests, or a test equivalent to these tests, in addition to using chest x-ray examinations. Health security for the United States will be enhanced by the use of these updated medical screening methods.